BB&T Washington Writer

GAITHERSBURG, Maryland — An FDA meeting held in early November revealed a general revealed a general consensus on the merits of the agency's drive to develop a unique device identification (UDI) system in the industry, but the event also provided a forum for airing continuing concerns about how to do this. The development of what is being called a unique device identification (UDI) system is an FDA priotiy, according to Daniel Schultz, director of the agency's Center for Devices and Radiological Health (CHRH), noting that UDIs represent "a keystone" to broader efforts under way at the agency for improving patient safety.

Such an identification system is being pursued as a way to prevent product mix-ups and reduce medical errors; speeding recall efforts and ensuring their accuracy; combating counterfeiting by guaranteeing product pedigree; provding precise device identificaiton in cases of adverse events; and improving post-approval product surveillance. "We can do a better job of surveillance of products that are on the market," said Steve Stemkowski of Premier (Charlotte, North Carolina).

But trade associations representing device manufacturers — that would bear the initial and ongoing costs of UDI — said they weren't convinced that UDI would provide a safety benefit. As a result they appeared hesitant concerning any outright mandate by the FDA to implement an identification system, citing question marks concerning the agency's authority, absent any clear benefit of patient safety. "We'd like the FDA to prove that there are safety issues involved and that there's a necessity for it," said Jori Frahler, director of federal affairs for the Medical Device Manufacturers Association (MDMA; Washington). "We're not quite convinced that there's this need."

This view was echoed by Paul Pandiscio, who questioned the link between UDIs and safety in comments on behalf of the Advanced Medical Technology Association (AdvaMed; Washington). And Richard Eaton of the National Electrical Manufacturers Association (Rosslyn, Virginia) made the same point.

Emphasizing the need, Frahler told BB&T that drug identification systems are used in part to prevent harmful drug-drug interactions. In contrast, with devices, most patients typically receive only one, suggesting the need for a unique identifier. In addition, she said that healthcare professionals shouldn't have a difficult time recording such information in records.

Despite their concerns, the trade association speakers offered solutions for implementing UDIs Both AdvaMed and MDMA called for a single, globally harmonized system applicable to worldwide regulatory bodies and businesses, as did many other speakers.

Frahler noted the need for "just one" system and Pandiscio stressed a "need to define" a worldwide standard to foster UDI adoption. He is employed by Johnson & Johnson (New Brunswick, New Jersey, one of many manufacturers with internal barcoding already in place — though such systems can't be substituted, one to another.

Eaton proposed a five-year period for companies to phase in any new rules. Frahler added that MDMA is advocating voluntary participation, but she suggested that a UDI benefit might pertain to certain devices, but not for all.

Similarly, Jim Keller of the nonprofit health services research agency, ECRI (Plymouth Meeting, Pennsylvania), suggested first tackling high-profile, high-risk products before worrying about UDIs for items of much lesser consequence, such as rubber gloves or cotton balls.

The FDA's position offers flexibility, according to Larry Kessler, the director of CDRH's Office of Science and Engineering Laboratories. Kessler said that the fDA wouldn't "shoehorn" all companies into a single rule. "It is not clear that one size fits all." Kessler also conceded that the agency's effots to get a sense of UDI costs have "proven a challenge."

But consultant John Eyraud estimated that manufacturers, with the effort, could face somewhat more than $400 million in costs, even without factoring in the integration of information technology. That could add between $246 million and $2.7 billion, he said. For hospitals, first-year investment costs could total $1.4 billion.

A representative of the American Hospital Association (Chicago) said that group is "committed" to implementing UDIs for devices. But Kessler stressed the importance of ensuring that as hospitals and device manufacturers move forward, they are "talking the same language." Marcel Salive of the Centers for Medicare & Medicaid Services said such a system would help distinguish benefits between products. "For us to pay, we'd like to see evidence of comparative effectiveness," he said. "This type of data can help us develop that evidence." Added AHRQ's Jon White: "We place a premium on information and data."Added Jon White of the Agency for Healthcare Research and Quality (Washington), "We place a premium on information and data."

While the meeting produced no consensus on how to put a UDI system into practice, a range of voices were heard and most would presumably be in accord with Keller's assessment that universal implementation is going to be "very difficult."

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